GAO: FDA Info on Supplements Incomplete

by David Pittman David Pittman Washington Correspondent, MedPage Today
March 21, 2013

WASHINGTON -- The FDA may not be receiving all reports of health problems associated with dietary supplements because consumers could be complaining to poison centers instead, a government report found.

Consumers may not inform the FDA of health problems linked to products, such as vitamins and minerals, through its adverse event reports (AERs) program. Instead, they are voluntarily making reports to poison centers, according to a study done by the Government Accountability Office (GAO).

The FDA received more than 6,300 AERs between 2008 and 2011; 71% of those came from industry as required by law. From 2008 to 2010, poison centers received over 1,000 more reports of adverse events linked to dietary supplements than did FDA for the same period, according to the GAO analysis released last week.

"FDA officials said that their greatest challenge to identifying potential safety concerns from AERs is the relatively small number of AERs the agency receives, and that -- depending on its review of the poison center data -- FDA may benefit from obtaining access to these data for analysis," the report stated.

The FDA told the GAO that negotiations are ongoing with the American Association of Poison Control Centers for the agency to receive this information, but a deal isn't yet final. Cost is a factor, it said.

Unlike with prescription drugs, the FDA doesn't approve dietary supplements before they are sold to the general public. The agency relies on postmarket surveillance, including AERs, to monitor products' safety, but said that most AERs "do not initiate or support such actions because it is difficult to establish causality between the product and the health problem based on the limited information in an AER," according to the GAO report.

The FDA also doesn't monitor how well it uses AERs to generate consumer protection actions, the GAO stated. For example, the agency could link AERs to potential widespread health problems with products or manufacturers.

"By collecting this information, it may be able to assess whether AERs are being used to their fullest extent," the report said. "In addition, FDA is not required to provide information to the public about potential safety concerns from supplement AERs as it does for drugs."

But making such information public could expand the FDA's use of AERs by increasing consumer awareness and understanding of potential health issues with dietary supplements, the GAO said.

Since 2007, the agency has required manufacturers, distributors, and packers to report any serious adverse events they receive to the FDA within 15 days.

The GAO, the watchdog arm of Congress, obtained and analyzed FDA data on AERs from January 2008 to September 2012. It added to that FDA enforcement action and procedures to examine the agency's monitoring of supplement safety.

The GAO also checked to see if the FDA had implemented its 2009 recommendations, such as "issuing guidance for new dietary ingredients, clarifying the boundary between dietary supplements and conventional foods, and expanding partnerships to improve consumer understanding."

While the FDA did develop draft guidance in 2009, 2011, and 2012 to address these GAO recommendations, they haven't issue final guidance for all of them.

"FDA officials said that they plan to complete implementation, but they have provided no time frame to do so," according to the GAO report. "With final guidance in place, firms may be able to make more informed product development and marketing decisions, which could ultimately reduce FDA's enforcement burden in these areas."

The FDA began regulating dietary supplements in 1994, mostly by requiring labels include ingredients and their quantity. Manufacturing standards came into force for supplements in 2010, but the agency has used its regulatory power over supplement makers infrequently.

However, the FDA has enacted some positive change. In 2004, it banned the sale of botanical ephedrine alkaloids, an herbal ingredient used in weight loss supplements that was linked to several deaths and which the GAO had reported on the year before.

And the agency did increase its inspections of supplement makers from 120 in 2008 to 410 for the first 9 months of 2012.

Dietary supplement sales surpassed $30 billion in 2011, and the CDC estimates almost half of U.S. adults took vitamins, minerals, and herbals from 2009 to 2010.

Lawmakers have said they intend to enhance the FDA's ability to act on public health issues associated with dietary supplements.

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